Definition

FDA's database containing adverse event reports and medication error reports submitted by manufacturers, healthcare professionals, and consumers.

Example

FAERS data is publicly available and used by FDA for post-marketing safety surveillance. Signal detection algorithms analyze FAERS data for emerging safety concerns.

Regulatory source

FDA

Common mistakes

Treating FAERS data as equivalent to clinical trial data. FAERS reports are unverified and subject to reporting biases.

Inspector question

Do you monitor FAERS for signals related to your products? How do you use publicly available FAERS data?

Related terms